Department of Transfusion Medicine, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria.
Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria.
Int J Mol Sci. 2021 May 13;22(10):5178. doi: 10.3390/ijms22105178.
Numerous cell-based therapeutics are currently being tested in clinical trials. Human platelet lysate (HPL) is a valuable alternative to fetal bovine serum as a cell culture medium supplement for a variety of different cell types. HPL as a raw material permits animal serum-free cell propagation with highly efficient stimulation of cell proliferation, enabling humanized manufacturing of cell therapeutics within a reasonable timeframe. Providers of HPL have to consider dedicated quality issues regarding identity, purity, potency, traceability and safety. Release criteria have to be defined, characterizing the suitability of HPL batches for the support of a specific cell culture. Fresh or expired platelet concentrates from healthy blood donors are the starting material for HPL preparation, according to regulatory requirements. Pooling of individual platelet lysate units into one HPL batch can balance donor variation with regard to essential platelet-derived growth factors and cytokines. The increasingly applied pathogen reduction technologies will further increase HPL safety. In this review article, aspects and regulatory requirements of whole blood donation and details of human platelet lysate manufacturing are presented. International guidelines for raw materials are discussed, and defined quality controls, as well as release criteria for safe and GMP-compliant HPL production, are summarized.
目前有许多基于细胞的疗法正在临床试验中进行测试。人血小板裂解液（HPL）是一种有价值的替代物，可替代胎牛血清作为各种不同细胞类型的细胞培养培养基补充物。HPL 作为一种原材料，可以实现无动物血清的细胞扩增，并高效刺激细胞增殖，从而在合理的时间内实现细胞治疗的人源化生产。HPL 的供应商必须考虑到与身份、纯度、效力、可追溯性和安全性相关的专门质量问题。必须定义放行标准，以表征 HPL 批次是否适合支持特定的细胞培养。根据监管要求，新鲜或过期的来自健康献血者的血小板浓缩物是 HPL 制备的起始材料。将个体血小板裂解物单位汇集到一个 HPL 批次中，可以平衡与必需血小板衍生生长因子和细胞因子有关的供体变异性。越来越多应用的病原体减少技术将进一步提高 HPL 的安全性。在这篇综述文章中，介绍了全血捐献的各个方面和监管要求，以及人血小板裂解液生产的详细信息。讨论了国际原材料指南，并总结了安全且符合 GMP 要求的 HPL 生产的定义质量控制和放行标准。
